Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

Patients will be treated until progressive disease, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever comes first.

E 04. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.

E 05. Less than 18 years (or country's legal age of majority if the legal age is >18 years).

E 13. Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.

E 14. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.

E 15. Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308567